NRG-GY028

A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Principal Investigator

Michaela Onstad Grinsfelder, MD, MPH

Status

Disease Site

Gynecologic [GY] Uterine Corpus

Phase

I/II

Developmental Therapeutics

No

Primary Objective

Phase I: Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose.

Phase II: Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid adenocarcinoma of the endometrium.Compare the toxicity of the combination of ipatasertib with megestrol acetate to megestrol acetate alone.

 

Patient Population

Patients with grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer with measurable disease according to RECIST v 1.1. Patients may have received unlimited prior lines of therapy.

 

Target Accrual

84